HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life

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Brief Title

HORIZONS: Understanding the Impact of Cancer Diagnosis and Treatment on Everyday Life

Official Title

HORIZONS: a Cohort Study to Explore Recovery of Health and Well-being in Adults Diagnosed With Cancer

Brief Summary

      The purpose of this study is to invite all people diagnosed with cancer who meet the
      eligibility criteria to complete questionnaires before their treatment begins and at regular
      intervals over time to assess the impact of cancer and its treatment on people's lives in the
      short, medium and long term. We will explore a range of factors to determine their role in
      both recovery of health and well-being and self-management. Although it is known that people
      who have had cancer are likely to experience a number of physical and psychological problems
      as a result of the disease and treatment, it is not known what the 'typical' course of
      recovery of health and well-being looks like, how long it takes and how this can be
      influenced. We will determine pathways to recovery of health and well-being following cancer
      diagnosis (initially breast cancer diagnosed <50 years, Non-Hodgkin Lymphoma and
      gynaecological cancers) and identify what factors influence this. This includes assessing the
      relative importance of the person's illness, personal attributes, perceived burden of
      treatment, role of the environment they live in, including health / social care and personal
      networks of support, and their ability and capacity to self-manage. We will identify who is
      most at risk of problems and what environmental supports and resources people are able to
      mobilise to support their self-management. We will also explore who has the confidence and
      ability to manage during and beyond treatment and what factors influence this and whether
      this leads to earlier problem resolution and restoration of health and well-being. This
      knowledge will be used to develop and test future supportive interventions to enhance the
      rapid recovery of health and well-being - our long term aim being to design ways of helping
      people with cancer in areas we identify as problematic for them.
    



Study Type

Observational


Primary Outcome

Quality of Life in Adult Cancer Survivors (QLACS)

Secondary Outcome

 EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) & Visual Analogue Scale (VAS)

Condition

Breast Cancer Female


Study Arms / Comparison Groups

 Breast cancer
Description:  Women aged <50 years

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

3000

Start Date

August 2016

Completion Date

September 2021

Primary Completion Date

December 2020

Eligibility Criteria

        OVERALL ELIGIBILITY CRITERIA:

        Inclusion Criteria:

          -  Have a new diagnosis of one of the selected cancer types determined through clinical
             assessment, cytology, histology or imaging or

          -  Have new / second primary cancer at a site previously treated for cancer

          -  Be awaiting primary curative intent treatment, including neoadjuvant treatment

          -  Be ≥16 years old.

          -  Be able to complete questionnaires in English

          -  Be able to provide written, informed consent

        Exclusion Criteria:

          -  They do not have one of the specified cancer types

          -  Disease is recurrence / progression (either locally advanced or metastatic) at an
             existing cancer site

          -  They are having treatment for a potentially curative recurrence of disease e.g.
             locally advanced disease (i.e. they have been previously treated for the same cancer)

          -  They have metastatic disease from a cancer at another site (Previous diagnosis of
             cancer at any other site would not be grounds for exclusion unless disease was
             metastatic)

          -  They have synchronous primary cancers involving two or more of the HORIZONS specified
             cancer types (Please exclude synchronous gynaecological primary cancers, synchronous
             breast and gynaecological primary cancers, synchronous breast and non-Hodgkin's
             lymphoma primary cancers and synchronous non-Hodgkin's lymphoma and gynaecological
             cancers)

        COHORT-SPECIFIC ELIGIBILITY CRITERIA:

        BREAST CANCER COHORT

        Inclusion:

          -  Women aged under 50 years old

          -  Stage 1, 2 or 3 breast cancer

          -  Have no distant metastases

          -  Patients due to undergo neoadjuvant treatment should be approached before this starts

        For those whose core biopsy shows ductal carcinoma in situ (DCIS) only but post-excision
        biopsy pathology confirms invasive cancer, approach should be made as soon as possible
        following diagnosis and completion of the baseline questionnaire should be prior to the
        start of adjuvant treatment

        Exclusion:

          -  Confirmed diagnosis of CIS (ductal or lobular) only

          -  Men

        NON-HODGKIN LYMPHOMA COHORT

        Inclusion:

          -  Any pathological diagnosis of Diffuse Large B Cell lymphoma (DLBCL) including;

          -  Secondary transforming or transformed DLBCL which has transformed from an indolent/low
             grade lymphoma (most commonly Follicular Lymphoma) as long as the low grade lymphoma
             was not treated and this is a recent transformation for which curative intent
             treatment has not yet started.

          -  Rare sub-types such as T cell rich Large B Cell Lymphoma and primary mediastinal
             (thymic) large B-cell lymphoma

        Patients who have started steroid pre-phase treatment are eligible for approach before the
        start of chemotherapy.

        GYNAECOLOGICAL CANCERS COHORT

        ALL GYNAECOLOGICAL CANCERS

        Gynaecological Cancer Exclusion criteria:

        Synchronous gynaecological primary cancers. For example, synchronous ovarian and
        endometrial primary cancers.

        OVARIAN CANCER SUB-COHORT

        Ovarian Inclusion criteria:

        Have a confirmed diagnosis either from cytology, histology, imaging or diagnostic primary
        surgery of either;

          -  Epithelial ovarian cancer including primary peritoneal cancer; fallopian tube cancer

          -  Ovarian carcinosarcoma

          -  Granulosa tumour of the ovary

          -  Patients should be entered prior to any treatment including surgery. However, where
             the diagnosis is only made at the time of surgery, these women may enter the study
             following surgery. Approach should be made as soon as possible following diagnosis and
             completion of the baseline questionnaire should occur prior to the start of adjuvant
             treatment.

          -  FIGO Stages: IA, IB, IC1, IC2, IC3, IIA, IIB, IIIA1

        Ovarian Exclusion criteria:

          -  Borderline ovarian cancer

          -  Germ cell tumour

          -  Sarcoma

        ENDOMETRIAL CANCER SUB-COHORT

        Endometrial Inclusion criteria:

        Have a confirmed diagnosis either from cytology, histology or imaging of;

          -  endometrial cancer

          -  endometrial carcinosarcoma

        Patients should be entered prior to any treatment including surgery. However, where the
        diagnosis is only made at the time of surgery, these women may enter the study following
        surgery. Approach should be made as soon as possible following diagnosis and completion of
        the baseline questionnaire should occur prior to the start of adjuvant treatment.

        - International Federation of Gynecology and Obstetrics (FIGO) Stages: IA, IB, II, IIIA,
        IIIB, IIIC1, IIIC2

        Endometrial Exclusion criteria

          -  Choriocarcinoma

          -  Germ cell tumour

          -  Sarcoma

        CERVICAL CANCER SUB-COHORT

        Cervical Inclusion criteria:

        Have a confirmed diagnosis either from cytology, histology or imaging of;

        - Cervical cancer FIGO Stages: IA2, IB1, IB2, IIA1, IIA2, IIB, IIIA, IIIB

        Cervical Exclusion criteria:

          -  FIGO stage IA1

          -  Cervical carcinoma in situ (CIS)

          -  Sarcoma

          -  Small cell cancer of the cervix

        VULVAL CANCER SUB-COHORT

        Vulval Inclusion criteria:

        Have a confirmed diagnosis either from clinical assessment, cytology, histology, imaging
        of;

          -  Vulval cancer

          -  FIGO stages IA, IB, II, IIIA, IIIB, IIIC

        Vulval Exclusion criteria:

          -  Basal cell carcinoma

          -  Melanoma

          -  Sarcoma

          -  Vulval intra-epithelial neoplasia (VIN)
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03000192

Organization ID

RHM CAN1199


Responsible Party

Sponsor

Study Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

 University of Southampton

Study Sponsor

, , 


Verification Date

March 2021